NCT00512850

Brief Summary

RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming. The use of folic acid may prevent colorectal cancer. PURPOSE: This randomized clinical trial is studying how well folic acid works compared with a placebo in preventing colorectal polyps in patients who have had previous colorectal polyps.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
672

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 1996

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1996

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2007

Completed
9.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

7.8 years

First QC Date

August 6, 2007

Last Update Submit

March 2, 2017

Conditions

Adenoma of Large Intestine

Keywords

Folic acidAdenoma of Large Intestine

Outcome Measures

Primary Outcomes (1)

  • Recurrent colorectal adenoma

    May 1996-March 2004

Secondary Outcomes (1)

  • recurrent adenoma by location, size, stage, number,

    May1996-March 2004

Study Arms (2)

Folic acid

OTHER

Folic acid supplement 1g/day

Dietary Supplement: Folic acid

Placebo

OTHER

Placebo pill once per day

Other: Placebo

Interventions

Folic acidDIETARY_SUPPLEMENT

Intervention group 1g folic acid per day

Folic acid
PlaceboOTHER

One placebo pill per day

Placebo

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participated in the Nurses' Health Study (NHS I) or the Health Professionals Follow-Up Study (HPFS) and have had a previous confirmed diagnosis of adenomatous polyp of the colon or rectum
  • Plan on having an endoscopy within 4 years after initiation of the trial
  • Must release medical records regarding past and any future endoscopies
  • PATIENT CHARACTERISTICS:
  • Plasma vitamin B12 concentration of ≥ 300 pg/mL or have a vitamin B12 concentration between 200 and 299 pg/mL and a methylmalonic acid (MMA) level ≤ 32 µg/L

You may not qualify if:

  • Diagnosis of cancer other than non-melanoma skin cancer, or early stage breast or prostate cancer
  • Diagnosis of homocystinemia
  • Diagnosis of pernicious anemia
  • Any gastrointestinal disorder that could lead to a vitamin B12 deficiency
  • Diagnosis of cirrhosis or pancreatitis
  • Diagnosis of epilepsy, Alzheimer's disease, Parkinsonism, and psychiatric disorders that may interfere with normal functioning
  • PRIOR CONCURRENT THERAPY:
  • No prior gastrectomy, total colectomy, or pancreatectomy
  • Other concurrent multivitamins or supplements that contain folic acid (they may take specific supplements, such as A, C, E, calcium, and iron, or antioxidant formula vitamins)
  • No concurrent methotrexate or anticonvulsant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Wu K, Platz EA, Willett WC, Fuchs CS, Selhub J, Rosner BA, Hunter DJ, Giovannucci E. A randomized trial on folic acid supplementation and risk of recurrent colorectal adenoma. Am J Clin Nutr. 2009 Dec;90(6):1623-31. doi: 10.3945/ajcn.2009.28319. Epub 2009 Oct 28.

    PMID: 19864409RESULT

  • Figueiredo JC, Mott LA, Giovannucci E, Wu K, Cole B, Grainge MJ, Logan RF, Baron JA. Folic acid and prevention of colorectal adenomas: a combined analysis of randomized clinical trials. Int J Cancer. 2011 Jul 1;129(1):192-203. doi: 10.1002/ijc.25872. Epub 2011 Apr 1.

    PMID: 21170989RESULT

MeSH Terms

Interventions

Folic Acid

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Edward L. Giovannucci, MD, ScD

    Dana-Farber/Brigham and Women's Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Edward Giovannucci, MD

Study Record Dates

First Submitted

August 6, 2007

First Posted

August 8, 2007

Study Start

May 1, 1996

Primary Completion

March 1, 2004

Study Completion

February 1, 2017

Last Updated

March 3, 2017

Record last verified: 2017-03